We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Institute for Clinical and Economic Review (ICER) has launched a cloud-based, cost-effectiveness modeling program for use by health technology assessment (HTA) agencies when projecting COVID-19 treatment costs. Read More
Two FDA expert panels voted in favor of FDA approval for Alkermes’s new drug application (NDA) for its schizophrenia and bipolar disorder investigational drug OLZ/SAM (olanzapine/samidorphan) in a joint session on Friday. Read More
China has officially agreed to support the World Health Organization’s (WHO) COVAX initiative, according to a foreign ministry spokesperson who did not provide the financial details. Read More
The European Commission has inked a supply deal with Gilead Sciences for 500,000 courses of the company’s antiviral drug remdesivir to shore up Europe’s depleting stocks of the COVID-19 treatment. Read More
The Government Accountability Office (GAO) wants the FDA to institute several changes to its three-year-old Office of Laboratory Safety (OLS), which was formed to improve safety in the agency’s labs that work with hazardous biological agents. Read More
Arbor Pharmaceuticals’ AR19, an abuse-deterrent formulation of amphetamine sulfate for attention deficit hyperactivity disorder (ADHD) should not receive FDA approval, two of the agency’s advisory committees voted unanimously in a joint meeting yesterday. Read More
In a move to show it’s a good corporate citizen during the pandemic, Moderna has vowed not to wield its COVID-19 related patents against other coronavirus vaccine manufacturers as the crisis continues. Read More
Regeneron Pharmaceuticals submitted a request for Emergency Use Authorization (EUA) for its COVID-19 antibody treatment Thursday, just one day after Eli Lilly filed for authorization of its own monoclonal antibody. Read More